European Union

Capitalise on the market opportunities in the European Union

The European Union consists of 28 member states located in Europe. For most products entering the EU, there are harmonised regulations (EU Directives) which need to be complied with depending on its product scope. Most directives will require a CE Mark, a mandatory mark that demonstrates a manufacturers’ compliance to applicable EU directives. Individual country requirements may also apply.

Market access information by category

Click on the respective blue bars below to get market access information for each category.

Electrical Safety

Regulatory agency

European Commission (EC)

Regulations

CE marking*, according to EU Directives, is mandatory.

DoC is sufficient but certification is recommended for marketing.

Product safety testing is required.

Compliance with European EN standards

* CE marking is not a certification, approval or quality mark, but a manufacturer’s declaration that the product meets the essential requirements of the respective directives. Most EU Directives require CE marking.

EMC

Regulatory agency

European Commission (EC)

Regulations

CE marking according to EMC Directive.

Environmental

Regulatory agency

European Commission (EC)

Regulations

ENERGY EFFICIENCY

The Energy-related Products (ErP) Directive has repealed the Energy-using Products (EuP) Directive, extending the scope of eco-design requirements to all ErPs.

The EC is still reviewing its effectiveness. For product categories with regulations in force, CE marking applies.

RoHS & WEEE

RoHS is a CE marking directive. Even though WEEE is not a CE marking directive, products must comply with the RoHS and WEEE Directives where applicable.

Telecom & Wireless

Regulatory agency

Regulations

DoC is sufficient but certification is recommended for marketing. Where there is lack of harmonised standards, it is necessary for manufacturers to engage a Notified Body*.

* Notified bodies are organisations that have been accredited by EU Member States to serve as independent test laboratories to access whether products meet the requirements of product directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives.

More information on EU regulations

Identify the directives that apply to the product. If more than one applies, all must be complied with.

Determine the extent to which the product complies with the requirements of the applicable directive(s).

Choose the conformity assessment procedure* based on the directive for your product.

Select the applicable product standards and test methods for your product and select an independent laboratory if the directive(s) states that product testing is to be done externally.

Compile the Technical File of technical documentation for your product. The Technical File holds information that verifies that the testing was conducted properly and that the product complies with applicable standards; it is product dependent.

Prepare a DoC declaring that the product fulfils the requirements of the applicable directive(s) with the legally binding signature of the manufacturer.

Affix the CE mark to your product. There are specific rules to adhere to in CE marking.

* Conformity Assessment Procedure options for products with minimal risk include DoC while products with greater risks may require tests, audits or additional certificates from a Notified Body.

Product groups with regulations according to the ErP Directive include:

Consumer electronics (televisions)

Electric motors

External power supplies

Household refrigerating appliances

Non-directional household lamps

Simple set-top boxes

Standby and off-mode losses

Tertiary sector lighting

To determine if a particular product is subject to the above regulations, please contact us.

TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with EU*(and individual country) requirements and obtaining the necessary approvals. The TÜV SÜD family is a Notified Body with the expertise and capability to test your product to a large variety of Directives.

* EU Directives are the minimum requirements that manufacturers must meet for products to enter the EU. However, individual country requirements may also be applicable.

** In addition to CE marking, which is simply a symbol for trade with the assumption of conformity, TÜV SÜD Marks are a certification of compliance with European (EN) standards.

Guidelines

CE MARKING PROCEDURE

Identify the directives that apply to the product. If more than one applies, all must be complied with.

Determine the extent to which the product complies with the requirements of the applicable directive(s).

Choose the conformity assessment procedure* based on the directive for your product.

Select the applicable product standards and test methods for your product and select an independent laboratory if the directive(s) states that product testing is to be done externally.

Compile the Technical File of technical documentation for your product. The Technical File holds information that verifies that the testing was conducted properly and that the product complies with applicable standards; it is product dependent.

Prepare a DoC declaring that the product fulfils the requirements of the applicable directive(s) with the legally binding signature of the manufacturer.

Affix the CE mark to your product. There are specific rules to adhere to in CE marking.

* Conformity Assessment Procedure options for products with minimal risk include DoC while products with greater risks may require tests, audits or additional certificates from a Notified Body.

Product groups with regulations according to the ErP Directive include:

Consumer electronics (televisions)

Electric motors

External power supplies

Household refrigerating appliances

Non-directional household lamps

Simple set-top boxes

Standby and off-mode losses

Tertiary sector lighting

To determine if a particular product is subject to the above regulations, please contact us.

Why choose TÜV SÜD

TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with EU*(and individual country) requirements and obtaining the necessary approvals. The TÜV SÜD family is a Notified Body with the expertise and capability to test your product to a large variety of Directives.